In House Clinical Research Associate - Trial Operations at Boston Scientific Corporation Malaysia

Machelen, East Flanders, Belgium -

Full Time

Start Date

Immediate

Expiry Date

13 Apr, 26

Salary

0.0

Posted On

13 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Regulatory Submissions, Document Management, IRB/EC Timelines, Problem Solving, Quality Audits, GCP Compliance, Team Collaboration, Communication Skills, Study Start Up, Ethics Committee, Clinical Trial Management Systems, Multi-tasking, Relationship Building, Fluency in French, Fluency in Dutch

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites. Manage multiple sets of essential regulatory documents across several studies and division portfolios. Develop and foster clinical research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies. Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking. Manage and problem solve site start up challenges that arise to mitigate impact to service level agreement and study goals. Develop, prepare, complete and track required regulatory, ICF and legal documentation. Support internal quality audits, regulatory inspections, as applicable. Provide updates to leadership on site start up activities, investigator readiness, regulatory submission, approval status, etc. Ensure compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WI, policies & procedures. Bachelor's Degree, or an equivalent combination of experience and education. 1-3 years' experience in the In-House Clinical Research Associate / Study Start up specialist experience. Experience in study submissions to the Ethics Committee in France Belgium and the Netherlands. Fluency (written and spoken), in French, Dutch and English. Additional languages are valued. Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment. Ability to work in a team environment and possess clear, concise communication & presentation skills - written and verbal. Must be comfortable interacting with clinical research site personnel and study teams via phone, email, and in meetings. Strong team player, collaborative spirit, and ability to build relationships and work cross-functionally. Research Coordinator or In-House Clinical Research Associate / Study Start up specialist experience. Experience working with Ethic Committee's. Experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems / eTMF.

Responsibilities

Coordinate activities for site regulatory submissions and essential document collection for clinical research sites. Manage site start-up challenges and ensure compliance with regulatory requirements.